TPF-LITT ARM for Urinary Incontinence
Study Summary
This trial assesses the safety & tolerance of a new prostate cancer treatment that's done in the office setting under local anesthesia to preserve organ function & reduce surg. risk.
- Urinary Incontinence
- Prostate Cancer
- Adverse Effects Surgery
- Magnetic Resonance Imaging (MRI)
- Ultrasound
- Sexual Dysfunction
- Urinary Dysfunction
- Prostate Biopsy
- Ablation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: 1 year
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
TPF-LITT ARM
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: TPF-LITT ARM · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 50 - 80 · Male Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Carter G, Clover K, Britton B, Mitchell AJ, White M, McLeod N, Denham J, Lambert SD. Wellbeing during Active Surveillance for localised prostate cancer: a systematic review of psychological morbidity and quality of life. Cancer Treat Rev. 2015 Jan;41(1):46-60. doi: 10.1016/j.ctrv.2014.11.001. Epub 2014 Nov 13.
- Cooperberg MR, Carroll PR, Klotz L. Active surveillance for prostate cancer: progress and promise. J Clin Oncol. 2011 Sep 20;29(27):3669-76. doi: 10.1200/JCO.2011.34.9738. Epub 2011 Aug 8.
- Hamdy, Freddie C., Jenny L. Donovan, J. Athene Lane, Malcolm Mason, Chris Metcalfe, Peter Holding, Michael Davis, et al.. 2016. “10-year Outcomes After Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1606220.
- Loeb S, Carter HB, Schwartz M, Fagerlin A, Braithwaite RS, Lepor H. Heterogeneity in active surveillance protocols worldwide. Rev Urol. 2014;16(4):202-3. No abstract available.
- Cooley LF, Emeka AA, Meyers TJ, Cooper PR, Lin DW, Finelli A, Eastham JA, Logothetis CJ, Marks LS, Vesprini D, Goldenberg SL, Higano CS, Pavlovich CP, Chan JM, Morgan TM, Klein EA, Barocas DA, Loeb S, Helfand BT, Scholtens DM, Witte JS, Catalona WJ; Collaborators. Factors Associated with Time to Conversion from Active Surveillance to Treatment for Prostate Cancer in a Multi-Institutional Cohort. J Urol. 2021 Nov;206(5):1147-1156. doi: 10.1097/JU.0000000000001937. Epub 2021 Sep 10.
- Al-Hakeem Y, Raz O, Gacs Z, Maclean F, Varol C. Magnetic resonance image-guided focal laser ablation in clinically localized prostate cancer: safety and efficacy. ANZ J Surg. 2019 Dec;89(12):1610-1614. doi: 10.1111/ans.15526. Epub 2019 Nov 3.
- Lee T, Mendhiratta N, Sperling D, Lepor H. Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Rev Urol. 2014;16(2):55-66.
- Walser E, Nance A, Ynalvez L, Yong S, Aoughsten JS, Eyzaguirre EJ, Williams SB. Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low- to Intermediate-Risk Disease. J Vasc Interv Radiol. 2019 Mar;30(3):401-409.e2. doi: 10.1016/j.jvir.2018.09.016.
- Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
- Simmons, Lucy A M, Abi Kanthabalan, Manit Arya, Tim Briggs, Dean Barratt, Susan C Charman, Alex Freeman, et al.. 2017. “The PICTURE Study: Diagnostic Accuracy of Multiparametric MRI in Men Requiring a Repeat Prostate Biopsy”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/bjc.2017.57.
- Bianco FJ, Martinez-Salamanca JI. Focalyx Dx, Bx, Tx et Apps: A novel contemporary fusion paradigm for the management of prostate cancer. Arch Esp Urol. 2016 Jul;69(6):353-63.
- Hu Y, van den Boom R, Carter T, Taylor Z, Hawkes D, Ahmed HU, Emberton M, Allen C, Barratt D. A comparison of the accuracy of statistical models of prostate motion trained using data from biomechanical simulations. Prog Biophys Mol Biol. 2010 Dec;103(2-3):262-72. doi: 10.1016/j.pbiomolbio.2010.09.009. Epub 2010 Sep 30.
- 2022. "TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05698576.
Frequently Asked Questions
Does this research endeavor accept individuals over the age of 55?
"This clinical trial is open to individuals aged 50-80. Those younger than 18 or older than 65 may still find a suitable study, as there are 90 trials for minors and 1459 studies available to those over the age of 65." - Anonymous Online Contributor
Are there still vacancies available in this experiment for participants?
"Affirmative. According to clinicaltrials.gov, the research is currently recruiting patients after its initial posting on March 16th 2022 and last update January 24th 2023. The trial seeks out twenty participants from a single medical centre." - Anonymous Online Contributor
Who can take advantage of this research opportunity?
"This clinical study is seeking 20 individuals aged 50-80 with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Patients must meet various criteria, including the ability to sign informed consent documents and complete follow up visits; an absence of urinary retention; a serum creatinine level below 2 ng/dL and a GFR above 45; PSA levels under 20 ng/ml; Multiparametric MRI scores 3-5 for piRADS evaluation of their prostate volume between 18-100 cc in size, indicating intermediate risk prostate cancer with less than 1/3 glandular tissue present." - Anonymous Online Contributor
How many participants are currently engaging in this research project?
"Affirmative. Clinicaltrials.gov corroborates that the research project, which was initially put forward on March 16th 2022, is proactively recruiting participants. So far it has sought 20 individuals at one trial site." - Anonymous Online Contributor